Type 1 diabetes (T1D) physiopathology is related to multiple defects in the interleukin-2 (IL-2) pathway that compromise regulatory T cell (Treg cell) homeostasis and therefore immune tolerance.
In humans with T1D, there is an urgent need for the development of novel biomarkers of ongoing autoimmunity, especially nowadays when there is a growing number of novel immunomodulatory therapies that could be offered to at-risk subjects during the prodromal phase, when treatment could be more effective. Novel biomarkers could help to better define such individuals with high-risk of developing T1D.
Today, measurement of IAA autoantibodies—hereinafter AutoAbs—(which precede T1D onset), and T-cell responses to pancreatic β-cell and to the presence of the susceptibility HLA-DQ8 and DQ2 alleles are used for the diagnostic of T1D.
WO2005094200 describes compositions and methods for differentiating between type 1 and type 2 diabetes by measuring levels of protein markers adiponectin and leptin and discloses that said protein markers are differentially present in the samples of patients suffering from type 1 diabetes, type 2 diabetes and/or diabetic disorders as compared to samples of control subjects. WO2005094200 also discloses methods and kits that can be used as an aid for diagnosis of type 1 diabetes, type 2 diabetes and/or diabetic disorders by detecting these protein markers. The measurement of these protein markers, alone or in combination, in patient samples provides information that a diagnostician can correlate with a probable diagnosis of-the extent of type 1 diabetes, type 2 diabetes and/or diabetic disorder.